Clinical Trials Register

Summary
EudraCT Number:	2013-004447-23
Sponsor's Protocol Code Number:	Parity
National Competent Authority:	Finland - Fimea
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2014-02-21
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Finland - Fimea

A.2

EudraCT number

2013-004447-23

A.3

Full title of the trial

Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY): A Multi-Center Randomized Controlled Study Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resections with Endoprosthetic Replacements

Ehkäisevä antibioottihoito kasvainkirurgisissa tekonivelleikkauksissa

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Ehkäisevä antibioottihoito kasvainkirurgisissa tekonivelleikkauksissa

A.4.1

Sponsor's protocol code number

Parity

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Tays
B.1.3.4	Country
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Tampere University Hospital
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Tampere University Hospital
B.5.2	Functional name of contact point	Minna Laitinen
B.5.3	Address:
B.5.3.1	Street Address	Teiskontie 35
B.5.3.2	Town/ city	Tampere
B.5.3.3	Post code	33521
B.5.4	Telephone number	358331164880
B.5.5	Fax number	358331169270
B.5.6	E-mail	minna.laitinen@pshp.fi
B.Sponsor: 2
B.1.1	Name of Sponsor	Tays
B.1.3.4	Country
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.1.1.1	Trade name	Zinacef
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline
D.2.1.2	Country which granted the Marketing Authorisation	Finland
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Zinacef
D.3.2	Product code	Zinacef
D.3.4	Pharmaceutical form	Concentrate and solvent for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.1.1.1	Trade name	Natriumklorid B. Braun 9 mg/ml infuusioneste, liuos
D.2.1.1.2	Name of the Marketing Authorisation holder	B. Braun Melsungen AG
D.2.1.2	Country which granted the Marketing Authorisation	Finland
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Natriumklorid B. Braun 9 mg/ml infuusioneste
D.3.2	Product code	Natriumklorid B. Braun 9 mg/ml infuusioneste
D.3.4	Pharmaceutical form	Concentrate and solvent for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Concentrate and solvent for solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Postoperative infection prevention

Ehkäisevä antibioottihoito

E.1.1.1

Medical condition in easily understood language

Postoperative infection prevention

Ehkäisevä antibioottihoito

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.1
E.1.2	Level	PT
E.1.2	Classification code	10050861
E.1.2	Term	Limb prosthesis user
E.1.2	System Organ Class	10041244 - Social circumstances

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

In patients undergoing surgical excision and endoprosthetic reconstruction of a lower extremity bone tumor, is there any difference in the effect of postoperative antibiotic regimens (24 hours vs. 5 days) on infection rate outcomes?

Antibiootin suojaava vaikutus tekonivelleikkauksen jälkeen

E.2.2

Secondary objectives of the trial

In patients surgically treated for bone tumors of the lower extremities followed by limb reconstruction using an endoprosthesis, what is the impact of the postoperative antibiotic regimen (24 hours vs. 5 days) on the development of antibiotic-related complications (ie: gastrointestinal infections, fungal infections, etc.) and on patient functional outcome and quality of life after one year?

Tutkia onko 1:n ja 5:n päivän leikkauksenjälkeisellä antibioottihoidolla eroa

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Men and women of skeletal maturity (15 years of age or older);
2) Primary bone malignancies or benign aggressive tumors of the lower extremity;
3) Treatment by excision and endoprosthetic reconstruction;
4) Preoperative chemotherapy (non-compulsory);
5) Provision of informed consent

1) yli 15 vuotiaat potilaat
2)primaari luun maligniteetti tai aggressiivinen benigni luukasvain
3)hoito resektiolla ja tuumoriproteesirekonstruktiolla
4)preoperatiivinen sytostaattihoito
5)allekirjoitettu potilassuostumuslomake

E.4

Principal exclusion criteria

1) Methicillin-resistant Staphylococcus Aureus (MRSA), or Vancomycin Resistant Enterococcus (VRE) colonization*;
2) Allergy to study antibiotics Zinacef® (cefuroxime)];
3) Skeletal immaturity**;
4) Upper extremity endoprosthetic reconstruction;
5) Prior surgery in the affected limb (excluding a biopsy);
6) Revision surgery or prior infection in the limb***
7) Enrolled in a competing study

1) MRSA potilas
2) Zinacef allergia
3) luusto kehittyminen
4) yläraajasairaus
5) aiempi raajan leikkaus
6) aiempi raajan infektio
7) kilpailevan tutkimuksen osallistuminen

E.5 End points

E.5.1

Primary end point(s)

The primary study endpoint is the development of a deep surgical site infection (SSI) within 12 months following the initial surgery to treat a primary bone tumor of the lower extremities.

Tekonivelinfektio

E.5.1.1

Timepoint(s) of evaluation of this end point

Patients will be monitored regularly by the treating physician at 2 weeks, 4 weeks, 3 months, 6 months, 9 months, and 1 year.

2 viikkoa, 4 viikkoa, 3 kuukautta, 6 kuukautta, 9 kuukautta, 1 vuosi

E.5.2

Secondary end point(s)

The secondary study endpoints include patients’ functional outcome and quality of life, as well as antibiotic-related complications.

Funktionaalinen lopputulos, elämänlaatu, antibioottikomplikaatiot

E.5.2.1

Timepoint(s) of evaluation of this end point

3 months, 6 months, 9 months, 1 year.

3,6,9 kuukautta ja 1 vuosi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

hoidon eri pituus

different duration

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

1 year from the beginning

1 vuosi tutkimuksen aloittamisesta

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	Yes
F.1.1	Number of subjects for this age range:	5
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	Yes
F.1.1.6.1	Number of subjects for this age range:	5
F.1.2	Adults (18-64 years)	Yes
F.1.2.1	Number of subjects for this age range:	40
F.1.3	Elderly (>=65 years)	Yes
F.1.3.1	Number of subjects for this age range:	5
F.2 Gender
F.2.1	Female	No
F.2.2	Male	No
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	No
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	50
F.4.2	For a multinational trial
F.4.2.1	In the EEA	50
F.4.2.2	In the whole clinical trial	1042

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-03-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-03-25

P. End of Trial
P.	End of Trial Status	Ongoing

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